NCT06096233

Brief Summary

This clinical trial's primary aim is to investigate the acute effect of two exercise bouts (short \[10 minutes\] and long \[30 minutes\]) on appetite and appetite-regulatory hormone responses to a standard meal test. The secondary aim is to investigate when the changes in appetite and appetite-regulatory hormones occur during exercise. As an exploratory aim, the researchers will test if the two exercise bouts influence ad libitum energy intake in the periods after the standard meal test. The researchers will compare three groups (control, short exercise, and prolonged exercise) to see if the exercise bouts affect appetite, appetite-regulatory hormones, and energy intake in healthy men.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
5mo left

Started Nov 2023

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Nov 2023Oct 2026

First Submitted

Initial submission to the registry

October 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

October 11, 2023

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Peptide-YY (PYY)

    Blood samples will be drawn at different time points during the trial to measure the change in PYY blood levels. Area under the plasma concentration versus time curve (AUC) of PYY will be calculated using the trapezoidal rule.

    At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours

  • Change in Ghrelin

    Blood samples will be drawn at different time points during the trial to measure the change in ghrelin blood levels. Area under the plasma concentration versus time curve (AUC) of ghrelin will be calculated using the trapezoidal rule.

    At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours

  • Change in Glucagon-Like Peptide-1 (GLP-1)

    Blood samples will be drawn at different time points during the trial to measure the change in GLP-1 blood levels. Area under the plasma concentration versus time curve (AUC) of GLP-1 will be calculated using the trapezoidal rule.

    At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours

  • Change in subjective appetite sensations

    The subjective appetite sensations will be assessed using 100 mm visual analog scales (VAS) to measure appetite sensations (hunger, satiety, fullness, prospective food consumption, and desire to eat). The VAS are 100 mm long, with words anchored at each end expressing the most positive and negative ratings. Scores for each appetite construct range from 0-100.

    At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, and 6 hours

Secondary Outcomes (2)

  • Energy Intake

    At 5 hours

  • Macro-nutrient Intake

    At 5 hours

Study Arms (3)

Control

NO INTERVENTION

The participants will not perform any exercise.

Short Exercise

EXPERIMENTAL

The participants will run on the treadmill for 10 minutes.

Other: Bouts of Exercise

Prolonged Exercise

EXPERIMENTAL

The participants will run on the treadmill for 30 minutes.

Other: Bouts of Exercise

Interventions

The participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged).

Prolonged ExerciseShort Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males aged 18 years or older.
  • Have stable body mass for at least six months (within ±2 kg).

You may not qualify if:

  • Females
  • People who are younger than 18 or older than 65 years old.
  • Have food allergies.
  • Have significant contraindications to exercise (e.g., an injury that would inhibit running).
  • Smoking.
  • Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Lister Building at Glasgow Royal Infirmary

Glasgow, G31 2ER, United Kingdom

RECRUITING

Related Publications (2)

  • Broom DR, Miyashita M, Wasse LK, Pulsford R, King JA, Thackray AE, Stensel DJ. Acute effect of exercise intensity and duration on acylated ghrelin and hunger in men. J Endocrinol. 2017 Mar;232(3):411-422. doi: 10.1530/JOE-16-0561. Epub 2016 Dec 20.

    PMID: 27999089BACKGROUND
  • Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.

    PMID: 10702749BACKGROUND

Study Officials

  • James Dorling, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 23, 2023

Study Start

November 6, 2023

Primary Completion (Estimated)

October 5, 2026

Study Completion (Estimated)

October 5, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The stored data will be anonymous and follow the guidelines of the General Data Protection Regulation enforced in May 2018. Hard copies of participant information forms, including consent forms and dietary intake records, will be kept in locked filing cabinets. Keys to the filing cabinets will only be available to the primary investigator. All databases will be password protected and stored on a university computer with firewalls. Participants' identifiable data will be stored in a locked cabinet. Digital data will be stored anonymously within the server of the University of Glasgow. This project's Principal Investigator will be responsible for sharing the research data. Data will be preserved in Enlighten, the official online repository of Glasgow University's research output.

Time Frame
The data will be available when the study is completed. Data will be preserved for 10 years.
Access Criteria
Data will be shared via the repository deposit (Enlighten). Only signatories of end-user agreements can access and use shared data.

Locations